Standard

NS-EN ISO 11137-2:2012

Jun 2012 Withdrawn

Note: This standard has a new edition: NS-EN ISO 11137-2:2015

Corrigendums and amendments are bought separately.

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Abstract

ISO 11137-2:2011 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

Document information

Standard from SN
Published: 1 June 2012
Withdrawn: 1 September 2013
Edition: 2012-03
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC, 98/79/EC

Product Relations

Replaced by: NS-EN ISO 11137-2:2013
Replaces: NS-EN ISO 11137-2:2007
Adopted from: EN ISO 11137-2:2012 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 11137-2:2007/AC:2009

Withdrawn

NS-EN ISO 11137-2:2007
Current product

Withdrawn

NS-EN ISO 11137-2:2012
Replaced by

Withdrawn

NS-EN ISO 11137-2:2013

NS-EN ISO 11137-2:2012

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NS-EN ISO 11137-2:2015

NS-EN ISO 11137-2:2013